This talk introduces the audience to the particularities of developing medical device software and the regulatory landscape that you must comply with. I’ll focus specifically on the processes and culture that enables the creation of medical software device documentation intended for auditors, without damaging (too much) the team velocity and spirit.

1. What about compliance?
Maintaining high speed in regulated environments
Write the Docs
Prague 2018

2. Vlad Știrbu
CompliancePal
vlad@compliancepal.eu
@VladStirbu
github.com/vstirbu
Write the Docs Prague2018
CompliancePal2018
Nokia2001
TUT Software Systems PhD2012

3. medical device

4. medical device software

5. “In short, software is eating the world”
Marc Andreessen
https://a16z.com/2016/08/20/why-software-is-eating-the-world/

6. agile software development

7. modern documentation tooling

8. devops culture

9. stakeholders expectations

10. developers
designers
architects
management
system administrators
end-users

11. standards and regulations

12. developers
designers
architects
management
system administrators
end-users
auditors

13. Regulations
● HIPAA: Health Insurance Portability and Accountability Act
● MDR: Medical Device Regulation

14. Standards
● IEC 62304: Medical device software
○ Software life cycle processes
● ISO 13485: Medical devices
○ Quality management systems
● ISO 14971: Medical devices
○ Application of risk management to medical devices

15. risk analysis and management

16. hazards → risks → mitigations

17. Software safety classification
death or serious injuryC
thorough design documentation
and testing
non-serious injuryB design documentation and testing
no injury or damage to healthA
design documentation and testing
not required

18. software of unknown provenance

19. compliance ∩ development team ≈ ∅

20. compliance activities ⇒ friction

21. documentation sprints

22. “transition... tasks from being implicitly
performed to explicitly scheduled”
Does Agile Kill Innovation, Jan Bosch
https://www.linkedin.com/pulse/does-agile-kill-innovation-jan-bosch/

25. build tools to support
compliance activities

26. compliance ∈ agile practices
● Risk analysis and management
● Traceability and verification
● Compliance checks

27. make documentation great again

28. make documentation suck less

29. vlad@compliancepal.eu